So You’re Telling Me There’s a Chance

Anything can happen. You’ve probably heard the claim that a million monkeys in front of a million typewriters would eventually type one of Shakespeare’s sonnets.  But good luck waiting for the release of “A Monkey’s Immortality Sonnet.”  In sports, old-time Dodger fans used to say, “Wait’ll next year,” and the next spring they thought, “Anything can happen.”  That is, until summer passed, and the Brooklyn Bums disappointed them again.  “Anything can happen” makes for great drama in movies too.  A barely .500 club fighter from South Philly wins the heavyweight title.  But it took two movies.  Bobsledders from tropical Jamaica go to the Winter Olympics.  Oh, wait, that was real.  But they didn’t win. 

In musings, sports and entertainment, “anything can happen” can be a source of fun and inspiration.  Not so much in the courts. 

Bonander v. Breg, Inc., 2012 U.S. Dist. LEXIS 132620 (D. Minn. Sept. 18, 2012), is a summary judgment opinion in a failure to warn pain pump case.  The doctor who inserted the pain pump in the plaintiff’s shoulder said he never read the product label.  Id. at 5.  He didn’t listen to sales reps.  Id.  He didn’t spend a lot of time reading Dear Doctor Letters and didn’t remember reading one from the defendant.  Id.  He didn’t expect medical device companies or their sales reps to be the ones who supplied him with information about the risks and benefits of their medical devices.  Id.  He relied instead on his training, the literature and his interaction with colleagues.  Id. 

So the defendant moved for summary judgment: no causation because a different warning from the defendant wouldn’t have mattered to this doctor.  Id. at *1.  He wouldn’t have looked at it, much less considered it. 

Sounds like a winner, right?  Unfortunately, anything can happen. 

The court denied the motion.  The reason?  Four years after the plaintiff’s procedure the doctor stopped using pain pumps for shoulder surgeries after seeing an article in a medical journal that linked pain pumps and the type of injury that the plaintiff had.  Id. at *8.  But that doesn’t undermine the doctor’s testimony that he didn’t consider risks/benefit information coming from medical device companies.  It underscores it.  He got this information from a journal. 

The court conceded that the doctor “did not rely on medical device companies to provide such information,” but concluded nonetheless that the doctor “may still have responded to a warning” that was communicated to him.  Id. at *11.  This reasoning has us thinking of Lloyd Christmas: “So you’re telling me there’s a chance.”   

The court also said that the doctor never “foreclosed the possibility” that he would have heeded a warning communicated to him by the defendant.  Id. at *7-8.  But more important, it seems, is that he never opened it.  We don’t think that summary judgment should be defeated by mere possibilities.  Inferences must be “reasonable.”  

Remember, this was summary judgment.  The plaintiff already had discovery and an opportunity to seek evidence and testimony from the doctor.  It wasn’t early spring in 1951 Brooklyn.  It was late summer with the Dodgers out of the pennant race.  Much like all those early Dodger seasons (at least, pre-1955), we think the court should have put an early end to things.

One Smelly Product, Two Defendants, and Two Different Results

Out of Illinois comes a medical device case with odd and smelly facts.  Smith v. Phoenix Seating Sys. LLC, 2012 U.S. Dist. LEXIS 127865 (S.D. Ill. Sep. 10, 2012).  The medical device was a wheelchair armrest called the 312G.  The plaintiffs bought it (and, earlier, the wheelchair) from the defendant, Apria Healthcare Group.  Plaintiffs installed the armrest themselves.  Id. at *2-3.  But not right away.  That’s the odd and smelly part.  Plaintiffs claimed that when they first received the armrest in the mail and opened its box, it smelled.  How bad?  So bad that they put it out of the house.  First they put it in the garage for a week.  That didn’t work.  It still smelled.  So they moved it outside – to the patio – for another 3-4 days to air it out.  While the opinion doesn’t make it seem as if this worked completely, it apparently worked enough for plaintiffs to install the armrest. Id. at *3-4.   

That didn’t go so well.  Plaintiffs claimed that each of them then suffered injuries from a toxic combination created by a gel contained in the armrest and the gel’s surface material.  Id. at *6, 17-18. 

They sued two defendants.  One was Apria, whose role appeared to be that of the direct seller.  Id. at *29, 30-31.  Apria faced negligent failure to warn claims.  The other defendant was Phoenix Seating Systems, who designed the armrest (the extent of their involvement in the design seemed to be in dispute), received the armrest from the manufacturer, repackaged it, applied some identifying labeling, and then sent it to Apria.  Id. at *13-14.  Phoenix faced various strict liability claims. 

Alright, so the facts are a little odd.  But what about the summary judgment decision?  Not odd at all. 

Phoenix wanted out because it wasn’t a manufacturer, because there couldn’t be a failure to warn plaintiffs who had such idiosyncratic reactions, and because medical device preemption applied.  The court rejected all these arguments.  Illinois product liability actions, according to the court, apply to “all persons in the distributive chain . . . including suppliers, distributors, wholesalers[,] and retailers.” Id. at *10 (quoting Hammond v. North Am. Asbestos Corp., 97 Ill. 2d 195 (Ill. 1983).  So it didn’t matter that Phoenix wasn’t a manufacturer.  The court also found a fact dispute as to whether the plaintiffs’ reactions were idiosyncratic.  So that argument didn’t work.  As to preemption – and take heed here -- the 312G armrest was cleared under §510(k).  But current law is that preemption only applies to devices approved under the PMA process, not those cleared under §510(k).  While we’ve argued here that it’s time for the Supreme Court to reconsider this, it hasn’t done so yet. 

So no preemption, and Phoenix stays in the case. 

The court saw Apria differently.  There was insufficient evidence in the record to establish that Apria was involved in the manufacture or design of the armrest, or that Apria had reason to know of any problem that needed to be warned about:

Apria alleges it did not manufacture the 312G, take any part in its design, have knowledge concerning the specific materials contained in the 312G, or have knowledge of complaints similar to plaintiffs’ instant grievances. . . .

As plaintiffs’ response does not address Apria’s argument concerning its lack of knowledge, plaintiffs do not dispute such allegations. Moreover, plaintiffs’ complaint does not allege Apria had any role in the 312G’s design or manufacture, or knowledge of the 312G’s alleged defective design or manufacture. Similarly, plaintiffs have not instantly offered evidence demonstrating Apria was involved in the 312G’s manufacture or design, or that other complaints or reactions to the 312G have ever been reported.

Id. at *29, *30-31 (record citations omitted). 

Plaintiffs had only negligent failure to warn claims against Apria, and those claims couldn’t survive summary judgment – not on this record.  Now, just like Phoenix, Apria had a hiccup.  It claimed to be exempt from liability under a “seller’s exception” to product liability claims, but the statute that contained that exception had been declared unconstitutional years earlier by the Illinois Supreme Court.  Id. at *24-45.  So that argument didn’t work.  Fortunately for Apria, its other arguments did.  No duty, no claim – regardless of how bad the armrest smelled.  So Atria gets out of the case. 

Sometimes odd facts make for ordinary law.

A Couple Of Interesting New Cases Forwarded By Our Readers

We like it when our readers contact us, even when it’s only to tell us that we made a mistake.  At least they’re paying attention.  But we like it most when our readers send us new opinions of interest − especially good ones.  The rapid exchange of information helpful to the defense of prescription drug and medical device product liability litigation is what the DDLaw blog is all about.

But once we receive good new cases, it becomes our responsibility to get the word out, and that’s what we’re doing today, even if we feel we’ve been a mite slow about it.

Eckhardt v. Qualitest

Two readers (Quinton Urquhart of Irwin, Fritchie, and Rachel Passaretti-Wu of Skadden) both sent us, in response to our “Conte Rejected Again” post, Eckhardt v. Qualitest Pharmaceuticals, Inc., C.A. No. M-11-235, slip op. (S.D. Tex. Aug. 9, 2012).  Eckhardt − guess what? − also rejected the notorious Conte theory that brand-name manufacturers could be liable for allegedly inadequate warnings accompanying competing generic drug products that they never sold.

Eckhardt is the latest of a number of cases to reject brand-name liability under Texas law.  As indicated in our Branded/Generic liability scorecard, Eckhardt builds on Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. Mar. 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003) and Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, slip op. at 1-2 (Tex. Dist. Dallas Co. May 7, 2010), in hewing to the traditional product liability axiom that manufacturers are the only ones that can be liable for their products.

We make that point because we were somewhat disturbed to read the Eckhardt court expressing “disappointment” with the quality of the briefing on both sides.  Slip op. at 2-3.  While we expect the other side to do things like throw in “two several-hundred-page depositions” without page citations, id., we’re not accustomed to seeing our side criticized for citing “cases that have no nexus with” relevant law.  Id.

That’s precisely what we try to avoid with our branded/generic scorecard.  If as is the case in Eckhardt, the jurisdiction in question has a statutory product liability scheme (like Texas, or Tennessee, Kentucky, and New Jersey to name a few), we try to note in our case summary.  That way we try to make it easy for defense counsel everywhere to cite to the most relevant cases, whether inside or outside any particular jurisdiction.

Anyway, the rest of Eckhardt is good.  It’s a “one-two punch” case − by that we mean (as is apparent from our Generic Preemption scorecard) that the generic defendants have also been dismissed on preemption grounds.  Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817 (S.D. Tex. April 30, 2012).  Thus, the one-two punch of preemption and product identification has effectively ended the case.

Eckhardt makes the following holdings that might be useful in future cases:

• The tenuous relationship of branded products to generic labeling was not sufficient to justify liability under any Texas product liability theory.  Slip op. at 4-5.
• Fraud and similar claims satisfy the statutory definition of “products liability” claims.  Id. at 6-7.
• Breach of warranty and consumer protection claims fail where the defendant did not make the product.  Id. at 8-9.
• Negligence and negligent misrepresentation fail because a non-manufacturer owes no recognized duty to persons using competing products.  Id. at 10-11.

Baker v. APP Pharmaceuticals

We thank old colleague Will Sachse of Dechert for sending along Baker v. APP Pharmaceuticals LLP, C.A. No. 09-05725 (JAP), slip op. (D.N.J. Aug. 21, 2012).  Baker contains an excellent description of the New Jersey presumption of adequacy of FDA-approved warnings:

In failure to warn cases involving prescription drugs, “[i]f the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration under the ‘Federal Food, Drug, and Cosmetic Act,’” there is a rebuttable presumption that the warning is adequate.  This is no ordinary rebuttable presumption.  “Compliance with FDA regulations” gives rise to “what can be denominated as a super-presumption[.]”  “[C]ompliance with FDA standards should be virtually dispositive of such claims.”  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced in [New Jersey Rule of Evidence] 301.”

 
Baker, slip op. at 12-13 (citations, but not quotation marks, omitted).

The New Jersey presumption suffers from ill-advised, judicially-created exceptions to the broad legislative mandate, but Baker held that neither of those applied.  There can’t be “deliberate concealment” of information that’s “publicly available in published scientific and medical literature.”  Slip op. at 9-10.  Moreover, the plaintiffs weren’t being honest with the court.  The information in question was, in fact, disclosed to the FDA.  Id. at 10-11.  (The concealment claim was also a preempted fraud on the FDA claim, but the court didn’t have to discuss that.)  Also, for case-specific reasons (after-the-fact timing, and the information involving a different drug), the court found no manipulation, “intentional” or otherwise, of FDA post-marketing regulatory processes.  Id. at 12-14.  Thus the FDA-approved warning was as a matter of law.

Of equal interest, the court in Baker held that, even if the warning had been inadequate, it couldn’t have caused any injury.  This is important, because there hasn’t been all that much New Jersey law on warning causation.  There’s Strumph v. Schering Corp., 606 A.2d 1140, 1148-49 (N.J. Super. App. Div. 1993) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (adopting dissenting opinion below), which establishes the warning causation principle in New Jersey.  There’s also Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005).  These are both cases where the prescribing physician already knew the information and didn’t read the warning.  Two favorable opinions for a jurisdiction with as much learned intermediary rule litigation as New Jersey strikes us as a little thin.

Baker’s now a third case in that category.  First of all the court took out the lamentable “heeding presumption.”  “The heeding presumption is rebutted, however, if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted.”  Slip op. at 14-15 (citation and quotation marks omitted):

Moreover, a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and considered the risk in prescribing the product.  In that case, the physician’s conduct is the superseding or intervening cause that breaks the chain of liability between the manufacturer and the plaintiff.

 
Id. at 15 (citations, quotation marks, and footnote omitted).  That happened in Baker.  Not only did the prescriber know of the alleged heparin-related risk, but he “stood by his decision to administer heparin” under the facts of the case.  Id. at 15-16.  Further blocking any causal inference was the physician’s failure to read labels for “frequently” prescribed drugs with which he was familiar:

[The prescriber] testified in his deposition that he does not read the label of drugs he prescribes often, which includes heparin.  Moreover, Plaintiffs concede that [the prescriber] never testified that he would have consulted a black box warning or “Dear Doctor” letter, or that he ever reviewed the Physician’s Desk Reference when prescribing heparin.  Therefore, a different warning would not have made a difference in [plaintiff’s] treatment or outcome because [the prescriber] would not have reviewed it.

 
Baker, slip op. at 16 (citation omitted).

There was also a case-specific superseding cause − the “fail[ure]” of the nursing staff “to follow its own heparin treatment protocol” and monitor the drug level in the plaintiff’s blood.  Id. at 16-17.

Therefore, Plaintiffs have failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the failure of the hospital to follow its treatment protocol, that was a substantial factor in causing or exacerbating [plaintiff’s] injuries.

 
Baker, slip op. at 17.

Thus, Baker is a nice causation triple play (prior knowledge, failure to read, and third-party superseding cause) in a jurisdiction where such precedent is most welcome.

Thanks to everyone who sends us cases − and keep them coming.

Schilf – Not as Good on Appeal

We received an update today from one of our correspondents on Schilf v. Eli Lilly & Co., a case in which the trial court granted summary judgment against plaintiffs’ claim that the defendant didn’t sufficiently warn about the suicide risks of its antidepressant drug.  We reported on this defense win here.  At the district court level, the court determined that South Dakota would follow the learned intermediary doctrine.  With that, the court then held that plaintiff could not show warning causation because the prescriber testified in his deposition that he still would have prescribed the drug even if he knew the information that plaintiffs claimed should have been warned about.  That was all very good.

But we’ve just learned that the 8^th Circuit saw things differently on appeal.  Schilf v. Eli Lilly & Co., 2012 U.S. App. LEXIS 16103 (8^th Cir. Aug. 3, 2012).  In short, the 8^th Circuit (in a de novo review) found that the prescriber’s testimony did not establish that he would have prescribed knowing what plaintiffs claimed he should have known. 

The things he should have known, according to plaintiffs, were that there had been 5 completed suicides in the defendant’s clinical trials, that a causal link had been established, and that the suicide risk is increased further in adolescents.  Id. at *6.  The 8^th Circuit believed that the prescriber’s deposition didn’t show that he knew these things – even at the time of the deposition.

For instance, while the prescriber testified that he was aware of an FDA Press Release on the suicide risk, it wasn’t clear whether he knew what was in the press release.  Id. at *9-10.  Also, while the prescriber said that he had seen something in the press about pediatric use of antidepressants, there was insufficient testimony on where he’d seen it or what it said.  Id. at *9.  The 8^th Circuit also took issue with the prescriber’s testimony that he would still prescribe today, finding it ambiguous as to whether this testimony was based on what the prescriber knew at the time that he prescribed or today.  Id. at *11-12.

All this seems very fact intensive.  And that’s where the good news lies.  This decision doesn’t undermine the availability of a warnings causation defense – a defense that shows that plaintiffs’ preferred warnings wouldn’t have mattered.  It is, rather, a holding that (correctly or not) the facts of this particular case don’t support such a defense at the summary judgment stage.  Of course, they can still support a defense jury verdict.

It’s obviously an unfortunate outcome – for now – for the defense.  But it’s not much more than that.  We can still ask at our prescriber depositions, “if you knew then what you know today would you have still prescribed to the plaintiff?”  Just be sure to make clear what the doctor knows today.

More breaking news - NJ Ortho-Evra

Thanks to Susan Sharko of Drinker for forwarding today's win in Hayes-Jones v. Ortho-McNeil Pharmaceutical, No. MID-L-3416-10, slip op. (N.J. Super. L.D. Aug. 3, 2012).  It's late on a Friday afternoon, and we're trying to get out for vacation, but we liked it, so we think you will too.

Hayes-Jones is a failure to warn case under Virginia law.  The facts are fairly complex because the decedent was a member of the military and several military prescribers were involved.  Also plaintiff was on and off the product at various times over the years.

Basically, the defense swept the board on summary judgment.  The warnings (dating from 2008) were adequate as a matter of law with respect to blood clots/pulmonary embolism, the alleged risk, because the risk was identified and and warned about in detail.  Slip op. at 11-14.  The prescribers who were deposed understood that risk very well.  Id. at 14-18.

Since the plaintiff couldn't win on the facts, she launched a frontal assault on Virginia's learned intermediary rule.  That assault failed in every aspect.  The court rejected an exception for drugs where the FDA mandates direct to patient warnings.  Slip op. at 19.  That "exception" hasn't been adopted by any court in decades.  The court also rejected a direct to consumer exception.  Id. at 20.  The court also held that there's no heeding presumption in Virginia.  Id. at 21.  Finally, the learned intermediary rule applies to subsequent as well as original prescribers.  Id. at 21-22.

That's two good learned intermediary/warning causation decisions we learned about today.  That takes some of the sting out of the loss in Schilf v. Eli Lilly & Co., No. 11-2082, slip op. (8th Cir. Aug. 3, 2012), which was more about how to read a particular physician's testimony than anything else.

Fifth Circuit Affirms Summary Judgment In Mesh Case

Thanks and congratulations to Christy Jones and Anita Modak-Truran of Butler Snow for letting us know about - and more importantly winning - today's decision in Smith v. Johnson & Johnson, No. 11-60624, slip op. (5th Cir. Aug. 2, 2012), affirming summary judgment in a vaginal mesh case.

Smith has two aspects, procedural and substantive.  Since the opinion deals puts procedure first, so will we.  Basically plaintiff tried to litigate on the cheap with respect to expert witnesses, and it backfired badly.

There are two types of causation in a warning case.  There's medical causation, meaning that the product must cause the injury.  Then there's warning causation, sometimes also going under the rubric of "legal" or "proximate" cause, meaning that the claimed defect in the warning must have affected the recipient's (here, the physician under the learned intermediary rule) conduct in some way that caused injuy.

In Smith, only the latter - warning causation - was seriously in dispute.  But plaintiff, as the deadline for designating experts passed, designated only experts who addressed medical causation.  Smith, slip op. at 3.  Aggravating plaintiff's failure was the complete inadequacy of the designations.  Id.  Then, after the defendant moved for summary judgment on warning causation, and long after the expert deadline had passed, the plaintiff responded with a conclusory affidavit from another purported expert who had never been designated at all.  Id.

The judge, quite understandably, threw out the untimely affidavit.  Id. at 5.

On appeal the Fifth Circuit held that the judge acted well within his discretion in refusing to countenance the plaintiffs' playing fast and loose with expert designation procedures:

[T[he documents upon which [the belatedly designated expert] relied were available prior to the original September deadline for designation of experts. . . .  [E]very one of [his] opinions could be elicited from their other expert witnesses. . . .  [D]efendants [were] prejudiced by the months of delay in expert designations, and a continuance would not have cured that prejudice due to the long history of delays in the case.  Denying the plaintiffs’ motion to designate . . . [the] expert was not an abuse of discretion.

Slip op. at 6.  That's good - plaintiffs get away with this kind of hide-the-expert game all too often.

The substantive part of Smith was even better.  It's a familiar story, but one that doesn't lose its cogency with retelling.  Under Mississippi's learned intermediary rule - which the court specifically held applies to both medical devices and drugs, slip op. at 7 - there simply isn't warning causation as a matter of law where the prescribing physician already knew everything the plaintiff alleges should have been disclosed.  Specifically, in this case the prescriber knew about the consequences of tearing of the mesh:

[The prescribing surgeon] testified that he was aware of the risks inherent in using [the mesh], and stated that he was personally aware of the possibility of adverse events including extrusion and erosion.  [He] had performed a number of surgeries using [the] mesh, and some of those patients had reported to him with erosions and tears.  [The surgeon] also testified that he read the “Contraindications” section of the [mesh] package insert, which advised that . . . mesh “in contaminated wounds should be used with the understanding that subsequent infection may require removal of the material.”  [He] saw infection as a very serious potential issue and took that possibility into account in deciding whether surgery with [the] mesh was the best option for [plaintiff].

Smith, slip op. at 8-9.  When the defense hits a home run like that with the prescriber's testimony, it should be, and was in Smith, all over.

Breaking News - Another Aredia Win

Another remanded Aredia/Zometa case has apparently bitten the dust.  See Ingram v. Novartis Pharmaceuticals Corp., No Civ-05-913-L, slip op. (W.D. Okla. July 18, 2012).  Ingram threw out all of the plaintiff's on warning causation grounds, a strong defense in this litigation, which involves a drug used to treat cancer.  A basic problem that plaintiffs face in such situations is that, when the alternative is likely death by cancer, most prescribing oncologists aren't going to be swayed by the possibility of a much lesser injury (with bisphosphonates, osteonecrosis of the jaw).  So an allegedly defective warning about the lesser injury won't deter anything.

The law, in Oklahoma as elsewhere, requires warning causation - some material change in prescriber conduct:
Slip op. at 6.

Even if the plaintiff establishes a duty to warn and a breach of that duty, she must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.

Slip op. at 4. Oklahoma is one of those unfortunate jurisdictions that applies a heeding presumption even in pharmaceutical cases, but for the reasons we discussed above, it was easily rebutted in Ingram.

[The prescriber] testified that had he known of [the drug's] potential complication of osteonecrosis of the jaw, he would have prescribed it for [plaintiff's decedent] anyway.  This testimony establishes that although the prescribing physician . . . would have read and heeded the warnings regarding [the drug] and ONJ, this would not have changed [the prescriber's] decision to prescribe it to [the decedent].

As is also common in these cases, plaintiff tried to salvage the case with lesser causation evidence - that the prescriber, while still using the drug, now gives various advice about dental issues.  Slip op. at 6-7.  That didn't work in Ingram because even the plaintiff's own expert (a Dr. Marx - is that Harpo, Groucho, Chico, or Zeppo?) admitted that the decedent already had ONJ. Slip op. at 8:

When this finding [pre-existing ONJ] is kept in mind, it is clear that plaintiff’s arguments regarding [the prescriber's] changed prescribing practices are insufficient to discharge her burden of proof on proximate causation.  As demonstrated above, [the prescriber] has unequivocally testified that had he known in January of 1999 that [the drug] had the potential complication of ONJ, he would have prescribed it for [the decedent] anyway.

Slip op. at 8.

The court also throws out plaintiff’s wrongful death claim, because it wasn't supported by any expert testimony.  We've commented previously about the weakness of many of the cases we're seeing after remand from the A/Z MDL, and judging by the expert testimony here, Ingram looks like another.

In any event put another one in the "W" column for the Hollingsworth Aredia team.

TPPs Hoisted By Their Own Petard?

We’ve chronicled many times the largely unsuccessful attempts of third-party payers (in unholy alliance with plaintiffs’ lawyers) to sue derivatively over alleged off-label promotion of prescription drugs and medical devices.  Basically, these insurers, having already set their premiums and recovered for their expenses, take “free shots” at trying to get money back for what are mostly medically valid and beneficial off-label uses.  That’s usually why they’ve lost − because they can’t prove that anybody was actually hurt.


Insurance companies complain about “free riders” all the time, and legitimately so.  But in filing these suits, those same insurers are trying to be free riders themselves.

But is the attempted free ride always that free?

Or, to put it differently, can the TPPs’ unholy alliance with the other side come unhinged?

Take a look at the allegations in Borreani v. Kaiser Foundation Hospitals, 2012 WL 2375323 (N.D. Cal. June 22, 2012).  The Borreani decision itself isn’t all that interesting − preemption hasn’t been a basis for federal question-based removal since before we’ve been blogging − but the wrongdoing alleged against the TPP defendant stems directly from its attempt to create a causation rationale in one of its prior off-label use lawsuits:

[Defendant TPP] discovered [drug manufacturer] was utilizing illegal strategies to market [a drug] for off-label use. . . .

Upon learning of this alleged illegal behavior, [TPP] filed suit against [manufacturer]. . . .

At trial, [TPP’s] agents testified that had the company known of [the drug’s] dangerous side effects, it would not have listed it as unrestricted in the formularies. They also represented that they intended to educate [their] physicians about the increased risk. . . .

According to plaintiffs, [TPP] has yet to notify its physicians of the [litigation] findings or to modify the formularies to include [the risk] as a side effect of [the drug] or of its generic version. . . .

Borreani, 2012 WL 2375323, at *1 (emphasis added)

The plaintiff in Borreani alleged that the TPP was her decedent's health insurer, that he took the drug (almost certainly the generic, although it’s not entirely clear), and that he died from the side effect that the defendant TPP had pledged − but failed − to warn its plan doctors about.  Id. at *2. The TPP, having loudly proclaimed in its off-label use litigation that it would act to curtail the off-label use, was allegedly liable in Borreani for not in fact doing what it claimed it would.  Id.

Frankly, we don’t think there’s a duty here either.  TPPs should no more be liable for allegedly defective (but unactionable post-Mensing) generic drug warnings than branded manufacturers − there’s simply no common-law duty to warn about the risks of a product that a defendant didn’t make or sell.

But we take a degree of grim satisfaction in seeing TPPs (post-Mensing generic plaintiffs are looking for non-manufacturer deep pockets and have largely struck out against branded manufacturers) being called to account on their extravagant allegations made in suits against manufacturers (our clients) over what they supposedly would have done if only they had known about off-label promotion.

Cases like Borreani thus pose the question that, if TPPs allege (to plead causation as plaintiffs in suits against our clients) they would undertake to do things, had they only known of this or that purported risk of off-label use − then if they don’t do the things they alleged after actually finding out, have they negligently failed to follow through on what were litigation-inspired pledges to start with?

The general theory is called “negligent undertaking” − that is, the assumption of a duty that doesn’t independently exist under the law to start with − such as to reduce allegedly risky off-label use.

We don’t know, but it looks like post-Mensing plaintiffs in search of viable claims might actually put the causation allegations of erstwhile TPP plaintiffs to the test.  TPPs, as we’ve pointed out, lose most of these suits, but they keep bringing them because there’s no down side for them, and occasionally some court lets such claims proceed.  Borreani is an example of a possible down side.  What one plaintiff’s lawyer might want a TPP to plead as a plaintiff, might come back to bite that TPP when construed by another plaintiff’s lawyer against the TPP as a defendant.

Our bottom line − anything that increases the TPPs’ litigation down side risk can only work to the benefit of our clients by deterring litigation generally.

Happy Fourth of July

When we had the Monday gig we had the option of blogging on most of the major holidays. We say "option" because we could have honored the holiday by not blogging at all, but that seemed too indolent even for us. We usually split the difference by not doing any heavy lifting. There would be some vague reference to recent legal developments, without the usual piercing analysis you have come to expect from us (okay, from all of us except this particular scribe). There would be a couple of lame allusions to popular culture. Then there would be a heartfelt holiday greeting at the end. It became something of a tradition. Why stop now?




Despite, or maybe because of, our former Monday stint, we developed an enhanced respect for those holidays that resisted the Monday fetish. Veterans Day is an example. When we were employed by the federal government, it was the one holiday we got that almost nobody else got. Maybe precisely because it is seldom part of an extended weekend and mini-vacation, the meaning of Veterans Day is more insistent. There are plenty of veterans among our friends and family, and on that peculiar, isolated day-off in November it invariably seemed like a good idea to pick up the phone and call them. And then there's Christmas, of course. That holiday will never be shoe-horned into the Monday rotation. Neither will Halloween. (Is it just us, or has Halloween over the last 25 years leapfrogged over Easter and Thanksgiving to become the second-biggest holiday? Putting aside whatever controversial religious aspects swirl around it, has Halloween become the absolutely perfect festival of imbecility?)



Now that we have resumed blogging and moved to the Wednesday spot, we are delighted to take the keyboard on July 4th, our favorite holiday. It is the mid and high point of the BBQ troika, and usually has better weather than Memorial Day or Labor Day. We say "usually." Not so much this year, at least not in the Delaware Valley. The thunder and lightning are predicted to humble any human-generated fireworks display. So we'll celebrate our nation's birthday by grilling indoors, eating Mexican appetizers and German sausages, and drinking Italian wine. When the political discussion gets too heated, we'll turn on the Comedy Central marathon of the most patriotic episodes of "30 Rock," "South Park," and "It's Always Sunny in Philadelphia." Philadelphia does July 4th better than anywhere else. We have the Welcome America festival, with music by that most American of musical groups, The Roots. The Independence Hall Tea Party will host its fourth annual Independence Day rally, "Celebrate American Exceptionalism." The Occupy folks promise some sort of orchestrated chaos. And because the Occupy movement is all about chaos, there will also be an event where an unendorsed Occupy spin-off called The 99 Percent Declaration will hold a Continental Congress 2.0 to petition the government for redress of grievances. Good times.



We unashamedly believe in American exceptionalism. How can we not, given what we do? Every week, the advance sheets furnish further proof that our legal system is a uniquely powerful expression of the marvels and pathologies of American culture. There is a new book out called America the Philosophical by Carlin Romano. Romano argues that Americans have elevated pragmatism to philosophical heights. We think there is less to this thesis than meets the eye, but it does put us in mind of those scenes in Apollo 13 where the scientists at the Space Center in Houston improvised brilliant solutions, not by sitting around theorizing, but by taking the relevant physical materials and seeing what they could do with them to save the astronauts' lives. The great Jacob Bronowski said that "the hand is the cutting edge of the mind." It's a pragmatic technique and it works. But if pragmatism is mostly technique, what end does that technique serve? Here we have nothing more weighty to offer than something we all already know: Americans love freedom. Freedom to do what? Pretty much anything, no matter how righteous or risible. We visited Hong Kong over 20 years ago, before the handover, when it was thought to be the most open economy on earth. That's what Milton Friedman believed, and who are we to dispute a Nobel prize winner? Here was a place where products competed on their merits, not hamstrung by tariffs or cultural or governmental barriers. All kinds of products from everywhere were advertised and sold. Sure enough, Japanese electronics and cars adorned neon signs on many of the buildings. French luxury goods abounded. What American goods were ascendant? Fast food, cigarettes, and movies. Conclusion? Americans are really, really good at fun stuff that is not necessarily good for you. You decide. This Hong Kong visit was before Apple triumphed with the iPod, iPad, etc., so now add those goodies to the list. The point remains. America is, in some high-tech, hyperactive, crazy way, still faithful to Paine, Jefferson, and those other long-haired troublemakers. For that all-too-short speck of time when we galumph around the planet, each of us should be able to take our best shot at pursuing happiness. The legal system is supposed to help us do that, partly by facilitating voluntary transactions, and partly by preventing or punishing fraud and force.



We're not going to wade very far into the debate over the SCOTUS decision that mostly upheld the Affordable Healthcare Act. There are a lot of things that can be said about both the opinion and the reaction to the opinion. Speaking of pragmatism, we've heard or read a lot of commentators who accuse Chief Justice Roberts of pursuing a pragmatic result in a manner similar to that other, earlier Supreme Court Justice Roberts, who performed the "switch in time that saved nine." Maybe Chief Justice Roberts was worried about how it would look if there were a string of decisions where the five Republican-appointed justices always voted to overturn Democratic laws and the four Democrat-appointed justices always voted to uphold them. Or maybe Chief Justice Roberts decided to rewrite the law to insert that tax zinger. Or maybe Chief Justice Roberts was weary with Justice Kennedy always being the swing vote. Or maybe he really believes his analysis. We can debate it all day long, now and for the next 50 years. The liberal vs. conservative perspective does not get one very far on this issue. Not only do we have Justice Scalia on the other side of the fence from Chief Justice Roberts, but we also have the two smartest legal thinkers of our time (yeah, yeah, our University of Chicago bias is undeniable) -- Judge Posner and Professor Richard Epstein -- lobbing in shots at what Chief Justice Roberts hath wrought. We hope we do not sound like nihilists or technicians when we confess that this is sort of fun. This Summer we are going to the cradle of philosophy and democracy, Greece, but we bet their courts do not offer the grist for the intellectual mill that ours do.



Meanwhile, on a day when we eat mountains of hot dogs, we tremble in the face of the class action lawsuit recently filed in Minnesota state court (removed to federal court) against ConAgra alleging that Hebrew National brand frankfurters are not kosher. The complaint contains causes of action for negligence, violations of consumer protection laws, and breach of warranties. Throughout the 195-paragraph complaint, the plaintiffs repeatedly allege that the packages falsely represent that the hot dogs consist of 100% kosher beef "as defined by the most stringent Jews who follow Orthodox Jewish Law." The complaint manages to quote from both Upton Sinclair's The Jungle and the company's clever "We Answer to a Higher Authority" ad campaign that started in 1965.  Some of the specifics of the complaint might prompt us to fill our plate with eggplant today, but boiled (or grilled or fried) down to its essentials, the complaint tells a story of a manufacturing process that does not fully comply with religious rules. That is sure to raise interesting issues of expert testimony and cognizable injury. Do different ethnic or religious groups enjoy different consumer protection rights?  The manufacturing process involves a number of players besides ConAgra.  Indeed, ConAgra does not seem to have had much to do with the worst (wurst?) alleged transgressions.  But ConAgra is the only defendant. ConAgra denies the allegations. The hot dog case has nothing to do with a drug or device, but we will still follow it, because the issues are interesting and relevant and because, frankly, we are among those consumers who happily pay a bit more for Hebrew National hot dogs. They simply taste better. How do we opt out?



Finally, on this most American of holidays, we cannot ignore the Eleventh Circuit's decision in Farias v. Mr. Heater Inc., 2011 WL 2354369 (11th Cir. June 21, 2012). Like the hot dog case, it suggests something screwy about the American melting-pot.  (By the way, whatever a melting pot is, it is one of the few cooking implements not being used for our holiday barbecue.)  Our friends at the Abnormal Use blog mentioned the Farias case yesterday, and we won't resist the opportunity to chip in our two cents. In Farias, the plaintiff purchased a Mr. Heater propane gas heater at a Home Depot for use in her home. (Last digression of the day. We once worked with an expert witness who was a professor of marketing. His main point was that advertising almost never creates primary demand. That is, cigarette ads might influence whether you would smoke Marlboros or Camels, but they could not turn non-smokers into smokers. Just like car ads do not make you want to drive. Plaintiff lawyers would always ridicule that point, but plaintiffs, in their depositions, almost always validated it. Anyway, this marketing professor considered it high comedy when companies names themselves "Mr. [fill in the blank]." He thought it was the most uncreative, unmemorable, stupid name for a business. He had a hobby of collecting signs, cards, and other detritus from businesses that adopted the name of "Mr. Something." We contributed Mr. Mulch and Mr. Bar Stool souvenirs to his collection. The professor would have laughed at Mr. Heater.) The plaintiff failed to close the valve on the propane tank before going to bed. Fire. Damages. Lawsuit for strict liability and negligence. The plaintiff, who spoke only Spanish, contended that the manufacturer breached a duty to provide bilingual warnings of the product's danger. Now, there is no general duty to supply bilingual warnings. The plaintiff relied on Stanley Indus. Inc. v. W.M. Barr & Co., 784 F. Supp. 1570, 1576 (S.D. Fla. 1992), where the court held that "[g]iven the advertising of defendants' product in the Hispanic media and the pervasive presence of foreign-tongued individuals in the Miami workforce, it is for the jury to decide whether a warning, to be adequate, must contain language other than English or a pictorial warning symbols." In Stanley Indus., the district court found that the manufacturer and seller "regularly and actively" advertised on Hispanic television, four different Hispanic radio stations, and in a Spanish language newspaper. By contrast, the plaintiff did not unearth such evidence in the Farias case. Home Depot had recently instituted a policy for all its vendors to use bilingual packaging, but that did not evince a targeted campaign. So after the litany we recited above of fire, damages, and lawsuit, add summary judgment.



That result seems fine. But it occurs to us that it might have been a close thing. If targeting a subgroup of consumers sets up a duty to tailor warnings specifically for that group, then watch out, because most sellers of consumer products do plenty of targeting. Look at marketing research documents, brand plans, and media plans. There is more often than not a significant degree of group targeting. Some plaintiff lawyers sink to their most condescending, oleaginous depths in trying to turn "targeting" into a bad word. That is not only doltish but supremely ironic. Have you ever seen where plaintiff lawyers run their ads? Any marketing textbook lays out the necessity of targeting groups of consumers. There is a reason why investment banks advertise during "Meet the Press" and not, say, during "Say Yes to the Dress." But here is the doctrinal issue that ends today's discussion. If warnings must be specifically addressed to the targeted groups, what does that mean in terms of their required content? Bilingual is relatively easy. But what if you really are targeting viewers of "Say Yes to the Dress"? Does your warning need to be different than if you are targeting members of AARP? Or readers of Soldier of Fortune? And here we must leave off and turn to our macaroni salad, because now we are about to enter territory that, at least for those of us prone to making bad, tasteless jokes, is target-rich. Don Rickles and Adam Carolla would have a field day. Talk amongst yourselves. Come up with your own jokes. Remember how lucky we are to dwell in this miraculous, freedom-loving land, and enjoy the Fourth of July.

This Just In … NJ Win on Innovator Liability

We direct your attention to Coundouris v. Wyeth, et al. No. ATL-L-1940-10, 2012 WL 2401776 (N.J. Super. Jun. 26, 2012).  It’s a Reglan decision (actually a decision that applies to 8 Reglan cases) that Dechert was directly involved in – so we can’t say much.  But we can tell it is worth a read :

·         NJ resident plaintiffs who ingested generic metoclopramide sued the manufacturers of brand name Reglan for failure to warn – what we and others have dubbed, innovator liability.

·         The Court granted the brand manufacturers’ motion to dismiss finding:

o   the claims were governed by New Jersey’s Products Liability Act, slip op. at 4;

o   under which liability is limited to “specific parties – namely the manufacturer or seller of a product,” slip op. at 6 -- hence, no brand liability without brand product usage;

o   the Supreme Court’s Mensing decision did not address or impact the issue of innovator liability under NJ law. 

Enjoy!

Not A WIn, Not A Loss

The recent decision in Mims v. Wright Medical Technology, Inc., 2012 WL 1681810 (N.D. Ga. May 11, 2012), is really neither a win nor a loss.  Like Gaul, the decision contains three parts, and we have comments as to each.


Very briefly, the case involves a total hip implant constructed from titanium.  After being implanted for over three years, it broke.

Design Defect

The first part of the opinion denied summary judgment on design defect claims.  The plaintiff’s expert, as is common in such cases, alleged that instead of being made out of titanium it should have been made out of cobalt-chrome alloy (“CCA”).  Mims, 2012 WL 1681810, at *2.  Of course, if the defendant had used CCA, the expert would then have alleged it should have been made out of titanium − anything to claim a defect.

The defendant moved for summary judgment, arguing that merely claiming an alternative design was not enough.  Id. at *3. That struck us as a little odd, since defendants are usually the foremost advocates of a strong alternative design requirement. The court held that since alternative design was essential to design defect litigation, that was enough to survive summary judgment:

One factor consistently recognized as integral to the assessment of the utility of a design is the availability of alternative designs, in that the existence and feasibility of a safer and equally efficacious design diminishes the justification for using a challenged design. The alternative safer design factor reflects the reality that it often is not possible to determine whether a safer design would have averted a particular injury without considering whether an alternative design was feasible. The essential inquiry, therefore, is whether the design chosen was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. Alternative safe design factors include: the feasibility of an alternative design; the availability of an effective substitute for the product which meets the same need but is safer; the financial cost of the improved design; and the adverse effects from the alternative.

Id. at *2.

Frankly, we don’t mind that particular ruling too much.  We could even see using this quote in one of our cases.

The real problem in Mims was that the defendant hadn’t separately moved to exclude the plaintiffs’ expert under Daubert.  The court latched onto that and refused to “consider the reliability” of the expert testimony on summary judgment.  Id. at *3.  This procedural two-step is worrisome in that it allows an expert opinion that may well be inadmissible to defeat summary judgment.  The general rule has been that only admissible evidence counts on summary judgment, and the court’s wielding of a procedural fine-toothed comb undercuts that rule.  One take-away from Mims is to make sure to file Daubert motions separately and in advance of summary judgment, depending of course on the pre-trial schedule in any given case.

Another more unusual suggestion:  We’ve had some success using preemption against this type of claim, see Greenwood v. Pennsylvania Hospital, 1999 WL 1133313, at *2-3 (Pa. C.P. Philadelphia Co. June 9, 1999) (claim that implant should not have been made from stainless steel held preempted), but it depends on the classification regulation.  We’ll explain.  There’s usually no preemption in Class II metallic implants like hip implants under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), but there can be − if there’s a “device-specific” regulation, and the plaintiff’s particular claim is “different from or in addition to” something in that regulation under 21 U.S.C. §360k(a).

There are device-specific regulations for essentially all medical devices − but unfortunately they’re usually one-paragraph long and thus don’t cover many aspects of the device.  These are the FDA’s identification and classification regulations.  However, they do frequently say something about the metallic composition of implants. There are several hip implant I&C regs, see 21 C.F.R. §§888.3300-3350, and we don’t know which one applies specifically to Mims.  Most of them mention only “cobalt-chromium-molybdenum,” which was the plaintiff’s proposed design alternative in Mims, so the preemption argument wouldn’t fly.

However, if §888.3310 were applicable to this implant, or if some plaintiff’s expert offered the same opinion against the manufacturer of a §888.3310 implant, there’s a decent preemption argument.  That’s because this section states, as to composition, that such devices are “made of alloys, such as cobalt-chromium-molybdenum and titanium alloys.”  Emphasis added.  In this device-specific regulation, the FDA has expressly stated that “titanium alloys” are okay.  Thus, our preemption argument in such a situation would be that since a device specific regulation specifies “titanium” as acceptable composition, a common-law claim that titanium construction alone is a defect would be preempted even under Lohr.

Warning Defect

The second part of the Mims opinion also denied summary judgment as to the plaintiffs’ warning claim.  2012 WL 1681810, at *4.  The defendant moved based solely on the warning’s adequacy.  That’s hard to do unless the relevant part of the warning is really detailed.  The description of the warnings in Mims suggests otherwise in that case.

We find it much easier to win summary judgment in warning cases on causation − that the prescriber already knew the allegedly omitted information or that the information wouldn’t have changed what the prescriber did or the warnings.  Supporting facts would also include the prescriber continuing to utilize the device, with no change in procedure, after the plaintiff’s injury.

The lesson from Mims is that warning summary judgment motions ideally should have a double-barreled approach of both adequacy and causation.

The court in Mims seemed to assume, without any evidence (at least none was cited) that a different warning might have led to a different outcome.  Maybe the issue simply wasn’t raised in the Mims motion, but again the court’s willingness to rely on less than admissible evidence is troubling, since summary judgment can be sought on the grounds that the plaintiff has no evidence on an essential element where the plaintiff bears the burden of proof.

Punitive Damages

The final third of the Mims opinion dismissed punitive damages claims as a matter of law because the defendant demonstrated that the implant complied with FDA regulations:

[T]he Court concludes that the Plaintiffs would not be able to establish by clear and convincing evidence culpable tortious conduct that would authorize the imposition of punitive damages. Moreover, punitive damages are typically not appropriate where the manufacturer has complied with regulatory standards.

Mims, 2012 WL 1681810, at *5 (citing Stone Man, Inc. v. Green, 263 Ga. 470 (1993); Welch v. General Motors Corp., 949 F.Supp. 843 (N.D.Ga.1996)).

This part of Mims almost makes up for the rest of it.  Preclusion of punitive damages by regulatory compliance is something we’ve advocated before, here.  We prominently mentioned the Stone Man decision that the court followed in Mims.  So we take this opportunity to applaud the third part of Mims.

A Tale Of Two – No, Three – Drugs

It was the best of times, it was … no, check that, it was the best of times.  In the recent decision, Wendell v. Johnson & Johnson, 2011 WL 6291792 (N.D. Cal. Dec. 15, 2011), the moving defendants all received summary judgment, so it was just the best of times.

 

Wendell itself is something of a three ringed circus, insofar as the facts involve three drugs – mercaptopurine (also known, for reasons unknown to us, as "6-MP," which has the advantage of being shorter), Remicaid, and Humira – and the interaction between their respective warnings.  The only simple thing about the facts is there is only one prescribing physician.

 

Here goes.

 

In 1998, the plaintiff’s decedent was diagnosed with inflammatory bowl disease (“IBD”), a nasty autoimmune condition.  Prescriber, who didn’t ordinarily review drug labeling – but did just enough to preclude summary judgment on that basis – began drug treatment.  Initially, the treatment featured Prednisone.  Unfortunately Prednisone is well-know among those who prescribe and use it (such as Bexis’ daughter, for a while) for causing adverse reactions approximately 100% of the time.

 

The decedent didn’t like the reactions, and Prednisone isn’t a very good long-term treatment for a chronic condition anyway.  Thus, by 1999, the prescriber went with 6-MP to try to get the decedent off Prednisone.   6-MP isn’t without its own risks, either.  “At the time [the prescriber] prescribed 6–MP he was aware of a paper reporting the occurrence of lymphoma [that’s a kind of cancer] in adults taking the drug.”  The prescriber warned the decedent about this, although he might have said “malignancy” rather than the precise type.

 

Apparently, the attempted substitution didn’t work all that well, because almost three years later the poor man is still taking both Prednisone and 6-MP. All this (and a lot of what follows) is from the “Background” section of Wendell, 2011 WL 6291792, at *1-5, by the way.

 

Still trying to get the decedent off Prednisone, the prescriber, now in mid-2002, discusses adding Remicade to the mix.  Remicade is an “anti-tumor necrosis factor” drug – an “TNF inhibitor.”  The tumor necrosis factor in the body causes inflammation, and inflammation is a major problem in a whole host of autoimmune conditions, including IBD.  Unfortunately, “tumor necrosis” means exactly what it sounds like – tumor death.  Tumor necrosis factor also kills tumors. Inhibit TNF, as this type of drug does, and one of the body’s defenses against cancer goes away.

 

Thus, Remicade (and probably all TNF inhibitors) is also associated with increased risks of malignancies.  It’s a trade-off:  almost a certainty of less inflammation for an increased risk of possible cancer.

 

The prescriber knew this, too. And “virtually always” informed his patients of an increased risk of tumors and malignancies.

 

In 2005 and 2006, more information became available about a possible synergistic effect between 6-MP and Remicade, involving a particularly dangerous form of lymphoma.  This development culminated in 2006 with an FDA black box warning about using these drugs in combination.

 

The prescriber was contemporaneously aware of all of this.  Fortunately, the stuff also worked.  By mid 2006, the decedent’s IBD was in remission.  He was taken off Remicade.

 

One problem with autoimmune conditions is that once they’re beat, they don’t always stay beat.  Half a year later, in November, the decedent had a relapse.  Instead of Remicade and 6-MP, the prescriber prescribed Humira and 6-MP. When asked why he had switched from one TNF inhibitor to another, the prescriber stated:

 

So in November ′06, we had been aware for some time of complication of hepatosplenic T-cell lymphoma, so that would have been part of my discussion with the family.  Ease of therapy is always a discussion with Humira versus Remicade.

Wendell, 2011 WL 6291792, at *4.

 

However, it was also true that, at that time Remicade bore the aforementioned black box warning about cancer risk, while Humira did not.  The prescriber said, essentially, that the black box didn't make much difference to him, since he already was aware of the risk and discussed it with his patients.  In addition to being easier to administer, Humir, also had (the prescriber said, we have no independent idea) a "superior" safety profile for other reasons, primarily being 100% human (as opposed to being produced from genetically modified mice) in its origin.

 

Wendell is a product liability suit, so necessarily the worst happened.  After using this second TNF inhibiter for seven months, the decedent got the nasty lymphoma warned about in the Remicade black box and died.

 

On this record the makers of Humira and 6-MP moved for summary judgment under the learned intermediary rule.  The maker of Remicade did not (also for reasons unknown to us).

 

The court granted the motions.

 

Here’s why.

 

The prescriber knew full well about the risks involved when he prescribed those drugs.  It didn’t matter that the black box warning was only on Remicade, because he saw it on that drug before prescribing the other one.

 

California law is quite good, going back even before Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004), on there being no duty – or no causation – where plaintiffs demand that physicians be warned about things they already know:

 

[The prescriber] knew of the risk of malignancies associated with 6–MP and Humira, but still prescribed the medication.  Thus, there is insufficient evidence to create a material dispute of fact as to whether the warnings that Plaintiffs contend should have been given would have changed [the decedent’s] treatment.

Wendell, 2011 WL 6291792, at *6.  Indeed, the prescriber had known about the risk of 6-MP since day one – and probably warned the plaintiff about it way back then.  Id.

 

Then it gets really interesting.  Plaintiffs love to claim than any post-injury change in prescribing habits means that the same change could have been induced earlier had only there been adequate warnings.  But rarely is there any real proof of this.  In Wendell the court required some supporting evidence, and when none was forthcoming, pitched the claim:

 

Nor is there evidence that a warning specific to pediatric patients or specific to treatments combining 6-MP with TNF-blockers would have led [the prescriber] to stop prescribing 6-MP alone or in combination. . . . Contrary to [plaintiffs’] contention, evidence that [he] ceased prescribing TNF-blockers in combination with 6–MP after [the decedent’s injury] does not prove that he would have changed his prescription practices based on the warning they suggest. A warning about rare occurrences . . . associated with therapy combining 6-MP and Remicade is bound to have less persuasive power than an instance of the disease affecting a doctor's own patient follow[ing] that therapy.

Id. at *7 (emphasis added).  In the end, the issue (at least as to 6-MP) boiled down to prescription despite prior knowledge, “[T]he undisputed fact is that [the prescriber] was already aware of the risk of lymphomas associated with 6-MP, but still chose to prescribe the drug.”  Id.

 

Touché.

As to Humira, given the timing of the first prescription, the causation fight was won for these reasons:

 

• As with 6-MP, a mere subsequent change in prescribing habits, with no additional affirmative evidence, did not mean that it would have happened earlier had there been different warnings.  Id.
• The “better safety profile” wasn’t linked to black box warnings, or to cancer risk at all, but to a 100% human origin product having fewer allergenic risks – a major concern with an autoimmune patient.  Id. at *8.
• With the prescriber already knowing about the risk, there’s no evidence that the different state of warnings (black box versus no black box) played any part in the prescription decisions.  Id.
• Since the prescriber had prescribed other drugs with cancer risks, whether or not the prescriber believed that Humira had that risk was not by itself causal.  Id.
• The plaintiff parents’ self-serving statements that they would never have allowed the treatment had they been warned, was immaterial, since the decedent was an adult and made his own treatment decisions.  Id.

 

In states like California, where the basic law concerning learned intermediary causation is well established, collecting analogous fact patterns where causation is defeated as a matter of law is the name of the game.  Wendell has some good ones.

 

Dear Doctor Letters As The Next Warning Frontier – Kapps Vs. Winter

Under the learned intermediary rule, for a warning claim to succeed, at a bare minimum the prescribing (or sometimes another) doctor at least has to read the allegedly defective warning.  After all, there’s a causation element to every warning claim – the defect (whatever’s allegedly wrong with the warning) has to cause the injury.  If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.  This common-sense notion, that a warning that’s not read cannot be causal, has been bedrock law in prescription medical product liability litigation for decades:

 

Alabama

 

In re Trasylol Products Liability Litigation, 2011 WL 2117257, at *5 (S.D.Fla. May 23, 2011) (applying Alabama law) (“no record evidence indicating that [the prescriber] read the warning that Plaintiff claims was inadequate”); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1293, 1296 (N.D. Ala. 2003) (prescriber “did not even read the package insert”; thus he “he did not rely on [defendant’s] warnings”).

 

Arizona

 

Gebhardt v. Mentor Corp., 15 Fed. Appx. 540, 542 (9th Cir. 2001) (“evidence at trial showed that [the prescriber] did not read or rely upon the allegedly inadequate warnings of the [defendant’s] device”) (applying Arizona law).

 

California

 

Ramirez v. Plough, Inc., 863 P.2d 167, 177 (Cal. 1993) (where plaintiff “neither read nor obtained translation of the product labeling . . . there is no conceivable causal connection between the representations or omissions that accompanied the product”) (over-the-counter drug case; plaintiff did not read warning); Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299, 308, 318-319 (Cal. App. 2008) (“[t]here can be no proximate cause where, as in this case, the prescribing physician did not read or rely upon the allegedly inadequate warnings promulgated by a defendant about a product”); Lord v. Sigueiros, 2006 WL 1510408, at *3-4 (Cal. Super. April 26, 2006) (prescriber “admits that he had not read the [drug’s] label before prescribing it to the decedent”), aff’d, 2007 WL 4418019, at *4 (Cal. App. Dec. 19, 2007) (“evidence does not raise an issue of material fact regarding causation because [the prescriber] testified that he did not read the warning label prior to or after prescribing [the drug] to [plaintiff]”); Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“the doctor who prescribed [the drug] . . . failed to read [the defendant’s] published warnings before prescribing the drug.  Because the doctor testified that he did not read the warning label that accompanied [the drug] or rely on information provided by [the manufacturer's] detail men before prescribing the drug to [plaintiff], the adequacy of [the] warnings is irrelevant") (applying California law); Latiolais v. Merck & Co., 2007 WL 5861354, at *3 (C.D. Cal. Feb. 6, 2007) (the “inserts played no role in his decision to prescribe” because “[the prescriber] could not recall if he ever read the package insert”), aff’d, 302 Fed. Appx. 756 (9th Cir. 2008).

 

Connecticut

 

Allen v. Mentor Corp., 2006 WL 861007, at *5, *7 (D. Conn. March 31, 2006) (prescriber “failed to inform himself with respect to the [device] by reading the [package insert], a source of which he was aware and failed to find and read”; “nothing to suggest that the warnings . . . affected [the prescriber’s] conduct since he did not read them”).

 

District of Columbia

 

Mampe v. Ayerst Laboratories, 548 A.2d 798, 802 (D.C. 1988) (prescriber “specifically stated on several occasions that he did not rely on the manufacturer's warnings as a source of information”; plaintiff “therefore could not prove that the alleged inadequacy in [defendant's] warning was a proximate cause of her injuries”).

 

Florida

 

Rounds v. Genzyme Corp., 2011 WL 692218, at *3 (M.D. Fla. Feb. 18, 2011) (prescriber’s “failing to read the warning” warranted dismissal); Fields v. Mylan Pharmaceuticals, Inc., 751 F. Supp.2d 1260, 1263 (N.D. Fla. 2009) (“[w]here a physician fails to review the warnings issued by the manufacturer, proximate cause cannot be established”).

 

Illinois

 

Tongate v. Wyeth Laboratories, 580 N.E.2d 1220, 1228 (Ill. App. 1991) (“that the physician failed to read the package inserts and the PDR negated any possible negligence on the part of the defendant and that the physician’s negligence was the intervening, independent and sole proximate cause”); Ashman v. SK & F Lab Co., 702 F. Supp. 1401, 1405 (N.D. Ill. 1988) (“[p]laintiffs offer no evidence that [the prescriber] consulted the [drug’s] label at the time he prescribed”).

 

Indiana

 

Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992) (“additional warnings would not have assisted [plaintiff] where the nurse [selecting the drug] did not read the label”).

 

Kansas

 

Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1235 (10th Cir. 2001) ([the prescribing nurse’s] “failure to read the label - a basic task which she was trained to perform - was an efficient intervening cause of [plaintiff’s] injury”) (applying Kansas law).

 

Louisiana

 

Felice v. Valleylab, Inc., 520 So.2d 920, 927 (La. App. 1987) (in “[the prescriber’s] own testimony she admitted that she had never read the warning label on the device itself, and that she had never read the manual.  An adequate warning or instruction would have been futile”); Hall v. Elkins Sinn, Inc., 102 Fed. Appx. 846, 849 (5th Cir. 2004) (the prescriber “acknowledges that he never read the warning . . . therefore, [defendant’s] warning (adequate or inadequate) played no role in the events leading to [plaintiff’s] injury”) (applying Louisiana law); Dykes v. Johnson & Johnson, 2011 WL 2003407, at *5 (E.D. La. May 20, 2011) (the prescriber “never read the warning, and thus the warning played no role in the events leading to plaintiff's injury”).

 

Michigan

 

Dunn v. Lederele Laboratories, 328 N.W.2d 576, 583 (Mich. App. 1982) (“the doctor quit reading the inserts and PDR reprints.  Thus, further notice by way of drug labels would not have altered the doctor’s conduct”); Formella v. Ciba-Giegy Corp., 300 N.W.2d 356, 359 (Mich. App. 1981) (the “fact [the prescriber] failed to read the package inserts and PDR negates any possible negligence on the part of [the manufacturer] in not emphasizing the hazards in those publications”); Cronin v. Boots Pharmaceuticals, Inc., 1996 WL 149173, at *2 (Mich. App. Feb. 16, 1996) (“[g]iven the lack of evidence that [the prescriber] ever consulted or relied on defendants’ package insert warnings in treating plaintiff, it cannot be said that those warnings played any role in the doctor’s decision to prescribe”); William Beaumont Hospital v. Medtronic, Inc., 2010 WL 3998103, at *6 (E.D. Mich. Oct. 8, 2010 (“failure to heed clear warnings can be a superceding cause”).

 

Minnesota

 

Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, at *23 (D. Minn. Sept. 27, 2011) (“doctors don’t read instructions for use in great detail every time”; plaintiff conceded unread warnings not causal); Treuchel v. Eli Lilly & Co., 2009 WL 5216930, at *12 (E.D.N.Y. Dec. 21, 2009) (“[plaintiff’s] prescriber did not rely on printed warnings. . . .  [Plaintiff] cannot meet his burden.  He failed to elicit any testimony from [any] prescriber suggesting that a different warning . . . would have changed the prescribers' decisions to continue prescribing [the drug] to [plaintiff]”) (applying Minnesota law); Johnson v. Zimmer, Inc., 2004 WL 742038, at *9-10 (D. Minn. March 31, 2004) (no causation where surgeon “had never, in any context, seen the warnings”).

 

Montana

 

Oakberg v. Zimmer, Inc., 211 Fed. Appx. 578, 581 (9th Cir. 2006) (“it is undisputed that neither [the prescriber nor plaintiff] read the [product’s] package insert.  Accordingly, even if the additional warning were printed in the package insert, they would not have been read”) (applying Montana law).

 

New Hampshire

 

Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 135, 146 (D.N.H. 2010) (the “[prescriber] made clear that he never reviewed [defendant’s drug] label before treating [plaintiff] and that nothing about it influenced his decision to prescribe the drug”); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *7 (D.N.H. Sept. 14, 2010) (“[plaintiff’s] doctor did not read or rely upon [the drug’s] label before prescribing the drug to her”).

 

New Jersey

 

Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1261 (N.J. 1999) (“a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all”); Strumph v. Schering Corp., 606 A.2d 1140, 1148, 1150 (N.J. Super. App. Div. 1993) (the “[prescriber] testified that he had not even read the PDR entry”; “conclud[ing] that plaintiffs failed to present any evidence from which a jury could reasonably find that the alleged inadequacy of defendant’s warnings regarding [the drug] affected the decision of plaintiff’s doctors to prescribe the drug”) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (expressly adopting dissenting opinion as the opinion of the court); Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005) (“there is every indication that Plaintiff's doctor, . . . did not read package inserts”).

 

New York

 

Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D. 2007) (“to prove proximate cause, a plaintiff has the obligation to adduce proof that had a warning been provided, she would have read the warning and heeded it”; plaintiff “chose not to read the consent forms”) (direct plaintiff warning claim); Banker v. Hoehn, 718 N.Y.S.2d 438, 441 (N.Y.A.D 2000) (“in the absence of reviewing any operating manuals for the [device]” by the prescriber, summary judgment granted on lack of proximate cause).

 

North Dakota

 

Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *4 (D.N.D. Sept. 5, 2000) (“[c]ase law supports the proposition that a physician’s failure to read the warnings, including package inserts and the Physician Desk Reference, essentially negates any possible liability on the part of the manufacturer).”

 

Ohio

 

Oppenheimer v. Sterling Drug, Inc., 219 N.E.2d 54, 58-59 (Ohio App. 1964) (prescriber “specifically said – ‘I don't recall specifically reading the precautions’”; “[i]t can hardly be said that he relied upon anything produced by the defendant”).

 

Pennsylvania

 

Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 458 n.3 (Pa. Super. 1973) (“[e]ven if [the manufacturer] had failed to adequately warn of dangers, said reason is not actionable in the case of a prescription drug, where the prescribing physician did not rely on the package insert”); Nelson v. Wyeth, 2007 WL 4261046 (Pa. C.P. Phila. Co. Dec. 5, 2007) (“[defendant’s] alleged failure to adequately warn could not have been the factual cause of [plaintiff’s injuries] since the prescribing physician did not read nor rely upon any of [defendant’s] warnings as contained in the label accompanying the prescription drug”), aff’d mem., 970 A.2d 489 (Pa. Super. 2009); Berry v. Wyeth, 2005 WL 1431742, at *5 (Pa. C.P. Phila. Co. June 13, 2005) (“[the prescriber] testified that he never read any warnings provided, thus any different warning (even a more adequate warning) would also have gone unread.  Therefore, [plaintiff] was unable to establish that [defendant’s] alleged failure to warn was the proximate cause”); Mazur v. Merck & Co., 767 F. Supp. 697, 712 (E.D. Pa. 1991) (“it is solely the responsibility of the learned intermediary to read [the package insert] and inform the patient of its meaning”; “[t]hat [the learned intermediary] may not have seen the package circular does not implicate [the drug company]”), aff’d, 964 F.2d 1348 (3d Cir. 1992).

 

Tennessee

 

Rodriguez v. Stryker Corp., 2011 WL 31462, at *11 (M.D. Tenn. Jan. 5, 2011) (prescriber “made the decision to use the pain pump entirely on his own”), reconsideration denied, 2011 WL 672555 (M.D. Tenn. Feb. 17, 2011).

 

Texas

 

Pustejovsky v. Pliva, Inc., 623 F.3d 271, 277 (5th Cir. 2010) (prescriber “did not recall ever reading the package insert for the drug or consulting the Physician's Desk Reference.  Her lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden”) (applying Texas law); Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999) (“[plaintiff] has failed to present evidence that the failure to warn was a producing cause of her injury [because] . . . the surgeon who . . . us[ed] the [product], testified that at no time prior to [plaintiff’s] surgery had he read [defendant’s] package insert or any other [of its] literature”) (applying Texas law).

 

Virginia

 

Stanback v. Parke, Davis & Co., 657 F.2d 642, 644, 645 (4th Cir. 1981) (prescriber’s testimony “established that he had not read the package insert accompanying the vaccine”; “[w]hatever may be said about [the prescriber’s] policies and . . ., it is clear that they precluded [defendant’s] failure to warn from having any effect whatsoever on [plaintiff’s] injury”) (applying Virginia law); Rule v. Best Industries, Inc., 1997 WL 499937, at *2, 121 F.3d 700 (4th Cir. Aug. 25, 1997) (“[the prescriber] did not even read the materials provided by [the defendant]. . . .  It would not have mattered what [defendant’s] warnings said, and the alleged lack of warning was not a proximate cause of [plaintiff’s] injury”) (applying Virginia law).

 

Washington

 

Douglas v. Bussabarger, 438 P.2d 829, 831 (Wash. 1968) (no proximate cause where the prescriber “did not read the labeling which was on the container)”.

 

West Virginia

 

Meade v. Parsley, 2010 WL 4909435, at *9 (S.D.W. Va. Nov. 24, 2010) (“[m]any courts have declined to find proximate causation in pharmaceutical failure-to-warn suits when the patient (or the prescribing physician if the learned intermediary doctrine is applicable) did not read the defendant manufacturer’s allegedly inadequate warning”) (plaintiff, since West Virginia does not recognize learned intermediary rule); In re Zyprexa Products Liability Litigation, 2009 WL 1514628, at *12 (E.D.N.Y. June 1, 2009) (“no evidence that [plaintiff] ever read any of defendant's warnings of possible risks”) (plaintiff, since West Virginia does not recognize learned intermediary rule) (applying West Virginia law).

 

Wyoming

 

Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 856 (10th Cir. 2003) (“when a physician fails to read or rely on a drug manufacturer's warnings, such failure constitutes the intervening, independent and sole proximate cause of the plaintiff's injuries, even where the drug manufacturer’s warnings were inadequate”) (applying Wyoming law).

 

We can see a few justifiable exceptions – such as affirmative overpromotion.  If a defendant’s detailer said “don’t bother reading the warnings” and the doctor didn't, then an obvious alternative means of causation presents itself.  Ditto, if the doctor read something else that originated with the defendant.  But the first seems vanishingly small (particularly nowadays), and the second is a reflection of changing media by which drug information is disseminated in the era of the Internet.

 

What we don’t want to see is a trend – possibly driven by post-Mensing plaintiffs forced by preemption to make Dear-Doctor-letter (called “Dear Health Care Provider (DHCP) Letters” by the FDA) claims – that Dear Doctor letters are some sort of deus ex machina Superman that makes causation problems vanish in failure-to-read situations.  It’s not really an argument to say “defendant should have sent a Dear Doctor letter at just the right time and the prescriber would have read it.”

 

So in that vein, we’ll look at two recent cases that have dealt with Dear Doctor letter issues – one that we think ultimately got it right, and another that we think didn’t delve nearly deeply enough into the nature of this sort of claim.

 

The first case – the good one – is the recent Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701 (D. Minn. Sept. 27, 2011), decision that we overviewed here.  Kapps was also a failure-to-read case (so we've cited it above), since the skilled tertiary care heart specialists who used the device weren’t about to consult the package insert concerning a device that they had undoubtedly used many times before.  Id. at at *23.

 

Regular readers may recall – but may not, so we’ll remind you – that the most unusual thing about Kapps was that the device had been reprocessed by someone (Ascent) unaffiliated in any way with the original manufacturer (Biosense), and the reprocessor had gone so far as to substitute its own name and labeling for the original manufacturer’s.  That led to the plaintiff’s primary causation problem:

Ascent usurped one of Biosense’s functions as a manufacturer – the function of providing instructions to customers – when Ascent replaced Biosense’s instructions for use with Ascent’s own.  Thus, if [plaintiff’s] claim depended on an argument that Biosense negligently failed to include certain warnings in its instructions for use, [that claim] would fail for lack of causation:  [plaintiff’s] damages could not have been caused by the omission of a warning from Biosense’s instructions for use, because Ascent replaced Biosense’s instructions with its own, and thus Biosense’s instructions did not accompany the catheter that injured [plaintiff].

2011 WL 4470701, at *23.  That’s actually a variant of the failure-to-read argument when you think about it, because the manufacturer’s instructions weren’t with the product any longer, and thus weren’t available to be read by anyone.

 

The plaintiff in Kapps, aware of this problem, advanced a Dear Doctor letter claim to fix his causation problem.  Such a “supplemental” warning, according to plaintiff, should have said “Dear Doctor, we have had a few reports of entrapment of this catheter in the mitral valve.  Please be very careful with its use in the atrium, et cetera.”  2011 WL 4470701, at *23.  Of course, plaintiff’s Superman-style letter would be sent to the medical community at just the right time to be read and heeded by the plaintiff's prescriber.  Id.  That’s what Superman does – show up at just the right moment (usually to save somebody falling).

 

Well, the court in Kapps lets Superman leap over the first obstacle, “at least for the sake of argument” – the manufacturer’s warnings not being with the product anymore didn’t necessarily defeat a Dear Doctor letter claim:

The fact that Ascent, in reprocessing the catheters, also became a manufacturer in some respects does not change the fact that Biosense was the catheters’ original manufacturer and sold the catheters to doctors. The Court therefore finds – at least for the sake of argument – that Biosense had a duty to warn doctors of the risk of mitral-valve entrapment.

Kapps, 2011 WL 4470701, at *23.

 

So where’s the kryptonite?

 

It might be in another argument – unfortunately not developed by the defendant – that the FDA might limit either the timing or substance of a Dear Doctor letter.  The plaintiff’s expert certainly didn’t have any idea.  2011 WL 4470701, at *24.  We don’t claim to know for sure, either, since the only regulation we could find with reasonable effort was 21 C.F.R. §200.5, which discusses what Dear Doctor letters should look like, but shies away from the more important question of when they are required.  This regulation just states “occasionally,” which doesn’t help very much.

There’s also an FDA “draft guidance” about Dear Doctor letters – something utterly without binding legal effect – that states that the FDA "should" be "consulted" about whether to send a Dear Doctor letter and what it should say.  Again, not all that helpful in litigation (other than as the basis for an expert opinion).  But that draft does tell us this:  Dear Doctor letters are for “important new information” – they’re not for rehashing something that doctors already should know:

[A] DHCP letter is used to inform health care practitioners about important new information about a drug.  In most cases, the new information is about an important new safety concern that could affect the decision to use a drug or require some change in behavior by health care practitioners, patients, or caregivers to reduce the potential for harm from a drug.  In some cases, the new information is about how to improve the effectiveness of a drug.

Draft guidance at 3 (emphasis added).  New.  New.  New.  New.  Moreover, Dear Doctor letters should “avoid discussion of non-critical information that could obscure the more important information.”  Id. at 4. The only other FDA-recognized use for a Dear Doctor letter is “to correct misinformation in advertising or other types of prescription drug promotion.”  Id. at 3.

 

Because the defendant didn’t have any regulatory argument developed, Superman got a free pass to leap over another obstacle:

[I] it seems reasonable to expect [plaintiff] to show that Biosense could have sent out the type of “Dear Doctor” letter that [plaintiff] calls for without violating those [unknown FDA] regulations.  But neither party has discussed the regulations covering “Dear Doctor” letters. The Court therefore will assume, for the sake of argument, that Biosense could have issued the warning advocated by [plaintiff].

Kapps, 2011 WL 4470701, at *24.

 

The court next identified, but passed by, another possible generalized causation argument, “also assum[ing], again for the sake of argument, that [plaintiff’s physicians] would have paid closer attention to a “Dear Doctor” letter than to instructions that accompanied the [device].”  Id.  No kryptonite yet.

 

Still, the plaintiff lost in Kapps.

Why?

Causation on the most fundament level.

Would the hypothetical letter have done any good in the plaintiff’s case?  No.  “[Plaintiff] cannot show that either [physician] would have done anything differently if Biosense had sent out the “Dear Doctor” letter proposed.”  2011 WL 4470701, at *24.  In short, the court found no evidence that Superman would have been able to save the day.

 

First, the plaintiff's Dear Doctor letter was garbage – or, as the opinion more gently puts it, “virtually content-free.”  2011 WL 4470701, at *24.  All it would have said was for surgeons “to be very careful” in light of “a few reports of entrapment of this catheter in the mitral valve.”  Id.  So what?  Doctors threading heart catheters are probably being “careful” anyway.

Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”?  Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.

Id. Well, duh.

 

Second, plaintiff in Kapps had no evidence – in particular no affirmative statements from either doctor – what different actions a Dear Doctor letter of the sort being proposed would have prompted.  One of the physicians wasn’t even deposed.  Thus as to him, “[t]here is not a shred of evidence in the record that, had [he] been warned that he should be careful about mitral-valve entrapment, he would have done anything differently.”  Id. at *25.  As to the other physician, who was deposed, he “testified that in the time since [plaintiff’s] procedure, [he] has not changed anything about how he uses [the device].”  Id.  If “direct personal knowledge” of a risk didn’t change anything, plaintiff’s vague Dear Doctor letter certainly wouldn’t have.  Id.

 

Third, not even a heeding presumption (not adopted in Minnesota) would have saved the claim.  Assuming (the Kapps opinion made a lot of pro-plaintiff assumptions, before throwing out the case) that such a thing existed, it only presumes heeding, not causation:

What is presumed under the heeding presumption is that the omitted warning would have been heeded, not that the heeding of the omitted warning would have prevented the plaintiff's injury. . . .  Biosense is being faulted for not warning [the physician] to “be very careful” in manipulating the [using the device].  But there is no reason to believe that [he] was not being very careful.  Put differently, there is no evidence that, if [he] had heeded the warning to be very careful, he would have done something differently – and thus there is no evidence that the absence of that warning caused [plaintiff’s] injuries.

Kapps, 2011 WL 4470701, at *25 n.22.

 

Finally, we have some kryptonite to kill the Dear Doctor letter Superman.

 

Kapps thus gives defense counsel a decent roadmap of the types of arguments that can defeat Dear Doctor letter-based warning claims:

 

• Is a Dear Doctor letter within the scope of the defendant’s duty to warn?  If the prescription medical product is not the defendant’s own product, unlike Kapps, where that was an important point, then probably not.  That’s why a Dear Doctor letter shouldn’t help a generic-only plaintiff against the branded manufacturer.  If the branded product isn’t being sold anymore – generally, or to this particular physician, or to this particular patient’s health plan – there shouldn’t be any duty to send such a letter.
• Is the defendant allowed by FDA regulations to send a Dear Doctor letter concerning the risk at issue?  From what little we’ve been able to discover in a few minutes on the FDA’s website, we’d have to say that the kind of “reminder” letters, "consistent" with existing labels, mentioned in some of the generic cases aren’t likely to pass muster.
• Is there evidence that Dear Doctor letters in general are likely to influence the plaintiff’s prescriber’s behavior?  How many such letters does he get?  Does s/he read them?  What kind of information actually changes prescribing behavior?  Examples?  Here, it would really help if either the defendant or, even better, the prescriber, had software installed that kept track of the prescriber’s receipt of and opening of Dear Doctor letters.
• Is there evidence that this particular proposed Dear Doctor letter would have changed the outcome of this particular case?  Other causation evidence – failure to read warnings; prior knowledge of the risk; “I wouldn’t do anything differently” testimony – will help here.  So would information that the same physician received Dear Doctor letters about other, equally or more serious, risks and still uses those products in the same way.  Again, software that keeps track of this kind of thing would be most useful.

So that’s Kapps.  On the other side of the ledger is Winter v. Novartis Pharmaceuticals Corp., 2011 WL 5008008, slip op. (W.D. Mo. Oct. 20, 2011).  Winter let a Superman-type warning claim (maybe a Dear Doctor letter; maybe something else – the opinion isn't entirely clear) save the day for the plaintiff.  Winter is a blatant failure-to-read case.  The prescriber wasn’t just ignorant – he was loudly ignorant.  He testified that he didn’t ever read any of the defendant’s drug labeling because the lot of it was “useless”:

[The prescriber] cannot recall a patient with [cancer] to whom he did not prescribe [the drug] prior to that point.  [The prescriber] has testified that he never read the package inserts for [drug] while practicing . . ., but that this was because [the defendant] produced them in a way that made them useless to a practitioner.

Id. at *1.

 

Here’s the first point where Winter sluffs off an issue.  Exactly how were the warnings “useless”?  The opinion doesn’t say.  We think that could be plenty important.  The format, almost entirely, as well as a lot of the content, of drug warnings is prescribed by FDA regulations.  Is this doctor saying that the FDA-mandated aspects of the label are why he finds it “useless.”  Does the doctor not read any drug labeling at all?  That would make causation impossible to prove, since such aspects of the label would be impossible for  the manufacturer to change.  Winter, however, passes by this issue entirely.

 

Anyway, for whatever reason, the doctor in Winter proclaimed his failure to read the relevant warnings.  Under the abundant precedent cited above, that should lead to a no-causation summary judgment ruling.

 

But here comes Superman (called “communications”) to the rescue.  Dear Doctor letters?  Sure.  In fact, one was apparently sent to onr non-reader prescriber in Winter.  But here comes an issue of fact – the same doctor who didn’t bother with package inserts, may not have bothered with Dear Doctor letters either, only we can’t be sure:

[Defendant] highlighted these latest changes in a Dear Doctor letter dated September 24, 2004, but the parties dispute whether [the prescriber] ever received this letter.

Winter, 2011 WL 5008008, at *1.  The same doctors who don’t read drug labels, probably don’t read anything else either – but when caught, they plead ignorance, and ta-da, that’s a “dispute.”  Here’s another example of a problem needing a technological fix.  Paper Dear Doctor letters leave no paper trail, unfortunately.  Software does.  Sending Dear Doctor letters by email means that a doctor who, as in Winter “ma[kes] himself ignorant,” id. at *2, won’t be able to hide behind that ignorance any longer.
 
Get modern - win cases.

 

Rather than actually grapple with (or at least mention) the causation questions, as Kapps did, the opinion in Winter contented itself with vague generalities:

But even assuming [defendant’s] claims are true, [plaintiff] has still shown that genuine issues of material fact exist as to causation on her claims.  First, [the prescriber] has testified that he did not read the package inserts for [the drug] medication because [defendant] produced these inserts in a way that made them useless to practitioners.

2011 WL 5008008, at *2.  Okay, but there’s not a scrap of affirmative evidence of causation in that statement.  How could anything different in an insert that’s “useless” change this doctor’s treatment?  No idea.  And if it’s inherent in how the FDA requires inserts to be drafted, then it would be afirmatively impossible.

 

Next.

Further, [plaintiff] has argued that [defendant] had a duty to reflect the known side effects of its medication in articles and communications through sales representatives, both of which could have reached [the prescriber] and changed the course of events despite his not reading package inserts.

Id. There's Superman.  Something, who knows what, saying exactly the right thing at exactly the right time.  What “communications”?  Could it be a Superman Dear Doctor letters – timed, of course, just right so that Superman can save the day?  Stay tuned.

 

But to us this sort of rank “could have” speculation doesn’t cut it – not where the plaintiff has the burden of showing causation.  There’s no mention of any evidence that this doctor – who didn’t read drug warnings, and couldn’t say if he’d even received Dear Doctor letters – read articles, let alone changed his practice in reliance on them.  Nor is there evidence that this doctor ever did anything in reliance on “communications,” either via Dear Doctor letters or in person via sales representatives.  If such evidence existed, we’d expect to see some mention of it in the Winter opinion, but we’re left scratching our heads.

 

Superman causation arguments – be they Dear Doctor letters, articles, or some sort of "underpromotion" by sales representatives, should require affirmative proof.  If a Dear Doctor letter is postulated, there needs to be evidence that the same doctor reacted positively to other similar letters involving comparable risks.  If an article (or a Dear Doctor letter) is postulated, there must be some basis that a proper basis for such an article (or letter) in fact existed at the “just in time” moment that the plaintiff's Superman swoops in.  The kind of mushy non-evidentiary, non-analysis in Winter makes a mockery of the burden of proof.

 

Not too long ago we took to task a pro-plaintiff law review article that whined about “evidence based medicine.”  Right now, we’d be happy just to have evidence-based litigation., instead of the Winter of our discontent.